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临床试验/NL-OMON55312
NL-OMON55312已完成3 期

A Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel-Group, Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute Kidney Injury - Recombinant human alkaline phosphatase SA-AKI survival trial / REVIVA

AM-Pharma B.V.0 个研究点目标入组 160 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
入组人数
160
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64（—）

入选标准

  • •1. 18 years or older.
  • •2. In the ICU or intermediate care unit for clinical reasons.
  • •3. Have sepsis requiring vasopressor (norepinephrine, epinephrine, dopamine,
  • •phenylephrine, vasopressin, or angiotensin II) therapy, i.e.:
  • •a) suspected or proven bacterial or viral infection
  • •b) on vasopressor therapy (>=0.1 µg/kg/min norepinephrine or equivalent) for
  • •sepsis-induced hypotension for at least one hour despite adequate fluid
  • •resuscitation according to clinical judgement. Following the initial one hour
  • •on at least 0.1 µg/kg/min norepinephrine or equivalent, any dose of vasopressor
  • •counts as vasopressor therapy.
  • •4. Have AKI according to at least one of the below Kidney Disease Improving
  • •Global Outcomes (KDIGO) criteria, a) to d):
  • •a) An absolute increase in serum or plasma creatinine (CR) by >=0.3 mg/dL (>=26.5
  • •µmol/L) within 48 hours
  • •b) A relative increase in CR to >=1.5 times pre-AKI reference CR value (see
  • •Section 8.3.3.3), which is known or presumed to have occurred within prior 7
  • •c) A decrease in urinary output to <0.5 mL/kg/hour for a minimum of 6 hours
  • •following adequate fluid resuscitation
  • •d) If the patient does not have a known history of CKD and there is no pre-AKI
  • •reference CR value (see Section 8.3.3.3) available from the past 12 months: a
  • •CR value greater or equal to the levels presented in Table 1, with the increase
  • •in CR presumed to have occurred within prior 7 days.
  • •5. Provision of signed and dated informed consent form (ICF) in accordance with
  • •local regulations.

排除标准

  • •1. At sites where enrolment of *moderate* CKD patients is allowed:
  • •a) Patients with 'severe' CKD defined as a pre-AKI reference eGFR <25
  • •mL/min/1.73 m2 are excluded.
  • •For patients with known CKD, the most recent eGFR prior to index
  • •hospitalization needs to be documented as >=25 mL/min/1.73 m2.
  • •For patients with known CKD but no known eGFR prior to hospitalization,
  • •presentation eGFR between 25-60 mL/min/1.73 m2 can also be used to rule out
  • •*severe* CKD.
  • •b) Where enrolment of 'moderate' CKD patients is NOT allowed, patients with
  • •'moderate' and 'severe' CKD defined as a pre-AKI reference eGFR <45 mL/min/1.73
  • •m2 are excluded.
  • •For patients with known CKD, the most recent eGFR prior to index
  • •hospitalization needs to be documented as >=45 mL/min/1.73 m2.
  • •For patients with known CKD but no known eGFR prior to hospitalization,
  • •presentation eGFR between 45-60 mL/min/1.73 m2 can also be used to rule out
  • •'moderate' and 'severe' CKD.
  • •2. Advanced chronic liver disease, defined as a Child-Pugh score of 10 to 15
  • •3. Acute pancreatitis without proven infection.
  • •4. Urosepsis related to suspected or proven urinary tract obstruction.
  • •5. Main cause of AKI not sepsis.
  • •6. Proven or suspected SARS-CoV-2 infection. This exclusion criterion does not
  • •apply to patients in the COVID-19 population , in which COVID-19 should be the
  • •main cause of SA-AKI.
  • •7. Severe burns requiring ICU treatment.
  • •8. Severely immunosuppressed, e.g. due to:
  • •hematopoietic cell transplantation within past 6 months prior to Screening or
  • •acute or chronic graft-versus-host disease
  • •solid organ transplantation
  • •leukopenia not related to sepsis, i.e., preceding sepsis
  • •Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS)
  • •receiving chemotherapy within 30 days prior to Screening.
  • •9. At high risk of being lost to follow-up (LTFU), e.g., due to known current
  • •or recent (within the last 6 months) IV drug abuse or known to be homeless.
  • •10. Limitations to use of MV, RRT or vasopressors and inotropes (NOTE:
  • •limitation of cardiopulmonary resuscitation (CPR) only is not an exclusion
  • •criterion).
  • •11. Previous administration of recAP.
  • •12. Use of a non-marketed drug within the last month or concurrent or planned
  • •participation in a clinical trial for a non-marketed drug or device. (NOTE:
  • •Co-enrollment or concurrent participation in observational, non-interventional
  • •trials using no protocolized treatments or procedures are always allowed.
  • •Co-enrollment or concurrent participation in trials using protocolized
  • •treatments or procedures, e.g. blood draws, requires pre-approval by the TSC).
  • •13. Current or planned extracorporeal membrane oxygenation (ECMO).
  • •14. On RRT >24 hours before start of trial drug.
  • •15. No longer on vasopressor therapy at time of randomization.
  • •16. On continuous vasopressor therapy for >72 hours before start of trial drug.
  • •17. Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2 based on the
  • •most recent available CR sample at time of screening (NOTE: will often be the
  • •sample used to diagnose AKI). eGFR should be calculated using the Chronic
  • 另有 2 项未显示

研究者

发起方
AM-Pharma B.V.

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